BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    QUANTITATIVE FIBRINOGEN ASSAY

    K Number: K963902 · Decision Nov 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    126
    Review Days
    63

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    Basic Information

    Device Name
    QUANTITATIVE FIBRINOGEN ASSAY
    K Number
    K963902
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    September 27, 1996
    Decision Date
    November 29, 1996
    Product Code
    GIS
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GIS Test, Fibrinogen

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